Congenital Heart DiseaseTORCH-LATAMNCT07799272
TORCH-LATAM: A Regional Pathway to Improve Transplant Evaluation for Congenital Heart Disease
A study testing TORCH Integrated Transplant Access Pathway (TORCH-ITAP) in people with Congenital Heart Disease, run by CardioVision International Tech, S.A.S. de C.V..
Trial summary
Congenital heart disease can progress to advanced cardiac or cardiopulmonary failure requiring heart, heart-lung, or, in selected congenital conditions, bilateral lung transplantation with cardiac repair. Read more about this study
- Who is it for?
- Ages 0 days and older
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- TORCH Integrated Transplant Access Pathway (TORCH-ITAP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Mar 2027to Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Confirmed congenital heart disease.
- Age from birth with no protocol-defined upper age limit.
- Advanced cardiac, pulmonary vascular, or cardiopulmonary deterioration meeting contemporary international criteria for transplant referral/evaluation, or previously documented transplant candidacy by an authorized program.
- Clinical presentation within the TORCH scope: heart transplantation; heart-lung transplantation; or, in selected congenital heart disease, bilateral lung transplantation with cardiac repair after multidisciplinary adjudication.
- Availability of the minimum baseline dataset required for standardized multidisciplinary evaluation and risk stratification.
- Written informed consent from the participant or legally authorized representative, with assent and re-consent as applicable under local requirements.
- Ability to undergo protocol-defined longitudinal follow-up.
- For participants referred from a non-transplant site, an operational referral route within the participating network to at least one authorized transplant center must exist. Prior acceptance by that transplant center is not required for trial enrollment; completion of specialist evaluation and the candidacy decision are post-enrollment trial processes/outcomes.
Who cannot join
- Absence of congenital heart disease or a transplant indication outside the TORCH congenital-heart-disease scope.
- No protocol-defined indication for transplant referral/evaluation after standardized review.
- A contemporary absolute contraindication to all transplant strategies applicable to the participant that is confirmed by multidisciplinary adjudication and is not considered reversible or re-evaluable under the protocol.
- Inability to obtain required informed consent/assent or to collect the minimum essential baseline dataset.
- A legal, regulatory, or safety condition that prohibits participation in research at the enrolling site.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: TORCH-LATAM: A Pragmatic Stepped-Wedge Cluster-Randomized Effectiveness-Implementation Trial of an Integrated Regional Pathway for Heart, Lung, and Heart-Lung Transplant Access in Pediatric and Adult Congenital Heart Disease
Congenital heart disease can progress to advanced cardiac or cardiopulmonary failure requiring heart, heart-lung, or, in selected congenital conditions, bilateral lung transplantation with cardiac repair. Access to transplant evaluation and organ utilization can vary across regions and institutions, and potential candidates who are never referred or evaluated are not represented in conventional waiting-list statistics. TORCH-LATAM is a pragmatic multicenter stepped-wedge cluster-randomized effectiveness-implementation trial evaluating the TORCH Integrated Transplant Access Pathway (TORCH-ITAP) in Latin America. Regional network clusters transition in a randomized sequence from usual care to TORCH-ITAP. The pathway standardizes early identification and referral, a common recipient dataset, multidisciplinary candidacy adjudication, structured donor-organ assessment, immunologic and anatomic-physiologic matching, preservation and transport traceability, and navigation of clinical, regulatory, logistical, and financial barriers. The primary outcome is the proportion of enrolled recipient participants who complete a standardized multidisciplinary transplant evaluation and receive a documented candidacy decision within 90 days. Secondary outcomes include activation of an official transplant pathway or waitlist where applicable, transplantation within 12 months, pretransplant death or irreversible deterioration, donor-organ utilization, post-transplant safety and survival, and implementation outcomes. Recipient participants constitute the ClinicalTrials.gov enrollment; donors, organs, donor-recipient matches, preservation strategies, and transplant episodes are nested analytic units. TORCH-ITAP does not allocate organs and does not supersede national transplant laws, authorized transplant programs, or governmental requirements for cross-border organ movement.
Read the detailed description
TORCH-LATAM evaluates a regional health-services intervention for pediatric and adult participants with congenital heart disease who meet protocol-defined international triggers for transplant referral/evaluation or who already have documented transplant candidacy. The intervention begins before official waitlisting. It follows a traceable cascade from identification and screening through consent and enrollment, standardized multidisciplinary assessment, candidacy adjudication, activation of an authorized transplant pathway, donor-organ opportunity assessment, immunologic and anatomic-physiologic matching, procurement, preservation, transport, transplantation, and follow-up.
The unit of randomization is a TORCH Regional Network Cluster rather than an individual hospital. A cluster is a functional network anchored in an authorized transplant center and may include referral/evaluation sites, donor-origin hospitals, procurement or preservation functions, and regional data coordination. Clusters begin in usual care and transition at randomized prespecified steps to TORCH-ITAP; after transition they remain exposed to the intervention.
TORCH uses layered eligibility. Recipient eligibility is separate from donor-organ eligibility, immunologic compatibility, anatomic-physiologic matching, and final transplant-episode feasibility. Donation after brain death and donation after circulatory death are donation pathways and are not synonymous with extended-criteria donation. Procurement/reperfusion strategies, preservation technologies, infectious or malignancy transmission risk, and extended preservation/transport exposure are captured as separate dimensions. Preservation technologies are not randomized by the parent protocol unless a future prespecified substudy introduces randomized assignment.
The primary confirmatory analysis follows intention-to-treat according to randomized cluster-period assignment. The primary outcome is analyzed with a generalized linear mixed model including intervention and calendar period as fixed effects and cluster as a random effect. Time-to-transplant and pretransplant death or irreversible deterioration are analyzed using competing-risk/time-to-event methods. Donor-organ utilization and preservation analyses use nested multilevel or observational methods appropriate to their unit of analysis. Predictive modeling is exploratory and is separated from the confirmatory analysis.
The digital platform implements a version-controlled Common Data Model with role-based access, audit trails, timestamps, structured reasons for clinical and operational decisions, and interoperable data elements. Platform development and testing with synthetic or non-identifiable data may occur before participant enrollment and does not constitute the ClinicalTrials.gov Study Start Date.
TORCH-LATAM does not create an organ allocation authority. Official listing, organ allocation, procurement, transplantation, and any cross-border movement remain subject to applicable law, competent authorities, institutional authorization, informed consent, and traceability.
- Conditions
- Congenital Heart Disease
- Being tested
- TORCH Integrated Transplant Access Pathway (TORCH-ITAP)
- Keywords
- Heart Transplantation, Heart-Lung Transplantation, Lung Transplantation, Health Services Research
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TORCH Integrated Transplant Access Pathway (TORCH-ITAP)Other
TORCH-ITAP is a multicomponent regional health-services pathway that standardizes early identification and referral, a common recipient dataset, multidisciplinary candidacy adjudication, structured donor-organ assessment, immunologic and anatomic-physiologic matching, preservation and transport traceability, and navigation of clinical, regulatory, logistical, and financial barriers. It supports authorized transplant pathways but does not allocate organs or supersede applicable law, competent authorities, or institutional authorization.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Phase | No intervention | Participants receive the site-specific usual transplant referral and evaluation pathway. Minimum study measurement is collected without activation of TORCH-ITAP. |
| TORCH-ITAP Phase | Experimental | The regional network implements TORCH-ITAP, including standardized identification and referral, common-data assessment, candidacy adjudication, donor-organ and match workflow, and structured navigation and traceability. Receives: Other: TORCH Integrated Transplant Access Pathway (TORCH-ITAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Completing Standardized Multidisciplinary Transplant Evaluation With a Documented Candidacy Decision
Percentage of enrolled recipient participants who complete the protocol-defined minimum multidisciplinary transplant evaluation and receive a final documented candidacy decision within 90 days. Final decisions include candidate/active pathway, candidate with a documented reversible condition/temporarily inactive status, not a candidate under current conditions, or an alternative transplant strategy within protocol scope. Deferred/incomplete evaluation does not count as success. Participants who die before final decision remain in the denominator and are classified as failures.
Measured: Within 90 days after formal trial enrollment
Secondary outcomes (5)
Activation of an Official Transplant Pathway or Waitlist
Percentage of TORCH-adjudicated candidates who enter an active authorized transplant pathway or official waitlist when applicable under local rules.
Measured: Within 6 months after candidacy decision
Receipt of Heart, Heart-Lung, or Selected Bilateral Lung Transplantation With Cardiac Repair
Cumulative incidence of protocol-scope transplantation after enrollment, with death or irreversible deterioration treated as competing events in prespecified analyses.
Measured: Within 12 months after enrollment
Pretransplant Death or Irreversible Clinical Deterioration
Cumulative incidence of death or deterioration that permanently prevents transplantation before transplantation.
Measured: Within 12 months after enrollment
Utilization of TORCH-Evaluated Donor Organs
Percentage of donor organs meeting the prespecified TORCH donor-organ opportunity denominator that are implanted. Final disposition is classified as implanted, recovered but not implanted, or not recovered. Prespecified reasons for non-use are recorded.
Measured: At final disposition of each donor organ (implantation or documented non-use)
Patient and Graft Survival
Organ-specific patient and graft survival after transplantation.
Measured: 30 days, 90 days, and 1 year after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study startMar 2027 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Stepped-wedge cluster-randomized trial represented in ClinicalTrials.gov as Crossover Assignment with two intervention conditions. Regional network clusters begin in usual care and cross over in a randomized prespecified sequence to TORCH-ITAP; once transitioned, a cluster remains exposed. New eligible recipient participants are enrolled consecutively within each cluster-period and are followed longitudinally after enrollment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CardioVision International Tech, S.A.S. de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Advanced Science Technologies
- Responsible party
- Sponsor
- Investigators
- Eliecer Villamizar De La Hoz., MD, Principal investigator, CardioVision International Tech, S.A.S. de C.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799272
- Sponsor's protocol ID
- TORCH-LATAM-001
- Acronym
- TORCH-LATAM
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TORCH-LATAM: A Pragmatic Stepped-Wedge Cluster-Randomized Effectiveness-Implementation Trial of an Integrated Regional Pathway for Heart, Lung, and Heart-Lung Transplant Access in Pediatric and Adult Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT07799272
- Acronym / sponsor ID
- TORCH-LATAM / TORCH-LATAM-001
- Conditions
- Congenital Heart Disease
- Keywords
- Heart Transplantation, Heart-Lung Transplantation, Lung Transplantation, Health Services Research
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- CardioVision International Tech, S.A.S. de C.V.Industry (pharma, biotech, devices)
- Collaborators
- Advanced Science Technologies
- Study start
- Mar 2027 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Congenital heart disease can progress to advanced cardiac or cardiopulmonary failure requiring heart, heart-lung, or, in selected congenital conditions, bilateral lung transplantation with cardiac repair. Access to transplant evaluation and organ utilization can vary across regions and institutions, and potential candidates who are never referred or evaluated are not represented in conventional waiting-list statistics. TORCH-LATAM is a pragmatic multicenter stepped-wedge cluster-randomized effectiveness-implementation trial evaluating the TORCH Integrated Transplant Access Pathway (TORCH-ITAP) in Latin America. Regional network clusters transition in a randomized sequence from usual care to TORCH-ITAP. The pathway standardizes early identification and referral, a common recipient dataset, multidisciplinary candidacy adjudication, structured donor-organ assessment, immunologic and anatomic-physiologic matching, preservation and transport traceability, and navigation of clinical, regulatory, logistical, and financial barriers. The primary outcome is the proportion of enrolled recipient participants who complete a standardized multidisciplinary transplant evaluation and receive a documented candidacy decision within 90 days. Secondary outcomes include activation of an official transplant pathway or waitlist where applicable, transplantation within 12 months, pretransplant death or irreversible deterioration, donor-organ utilization, post-transplant safety and survival, and implementation outcomes. Recipient participants constitute the ClinicalTrials.gov enrollment; donors, organs, donor-recipient matches, preservation strategies, and transplant episodes are nested analytic units. TORCH-ITAP does not allocate organs and does not supersede national transplant laws, authorized transplant programs, or governmental requirements for cross-border organ movement.
Detailed description
TORCH-LATAM evaluates a regional health-services intervention for pediatric and adult participants with congenital heart disease who meet protocol-defined international triggers for transplant referral/evaluation or who already have documented transplant candidacy. The intervention begins before official waitlisting. It follows a traceable cascade from identification and screening through consent and enrollment, standardized multidisciplinary assessment, candidacy adjudication, activation of an authorized transplant pathway, donor-organ opportunity assessment, immunologic and anatomic-physiologic matching, procurement, preservation, transport, transplantation, and follow-up.
The unit of randomization is a TORCH Regional Network Cluster rather than an individual hospital. A cluster is a functional network anchored in an authorized transplant center and may include referral/evaluation sites, donor-origin hospitals, procurement or preservation functions, and regional data coordination. Clusters begin in usual care and transition at randomized prespecified steps to TORCH-ITAP; after transition they remain exposed to the intervention.
TORCH uses layered eligibility. Recipient eligibility is separate from donor-organ eligibility, immunologic compatibility, anatomic-physiologic matching, and final transplant-episode feasibility. Donation after brain death and donation after circulatory death are donation pathways and are not synonymous with extended-criteria donation. Procurement/reperfusion strategies, preservation technologies, infectious or malignancy transmission risk, and extended preservation/transport exposure are captured as separate dimensions. Preservation technologies are not randomized by the parent protocol unless a future prespecified substudy introduces randomized assignment.
The primary confirmatory analysis follows intention-to-treat according to randomized cluster-period assignment. The primary outcome is analyzed with a generalized linear mixed model including intervention and calendar period as fixed effects and cluster as a random effect. Time-to-transplant and pretransplant death or irreversible deterioration are analyzed using competing-risk/time-to-event methods. Donor-organ utilization and preservation analyses use nested multilevel or observational methods appropriate to their unit of analysis. Predictive modeling is exploratory and is separated from the confirmatory analysis.
The digital platform implements a version-controlled Common Data Model with role-based access, audit trails, timestamps, structured reasons for clinical and operational decisions, and interoperable data elements. Platform development and testing with synthetic or non-identifiable data may occur before participant enrollment and does not constitute the ClinicalTrials.gov Study Start Date.
TORCH-LATAM does not create an organ allocation authority. Official listing, organ allocation, procurement, transplantation, and any cross-border movement remain subject to applicable law, competent authorities, institutional authorization, informed consent, and traceability.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Stepped-wedge cluster-randomized trial represented in ClinicalTrials.gov as Crossover Assignment with two intervention conditions. Regional network clusters begin in usual care and cross over in a randomized prespecified sequence to TORCH-ITAP; once transitioned, a cluster remains exposed. New eligible recipient participants are enrolled consecutively within each cluster-period and are followed longitudinally after enrollment.
| Arm | Type | Receives |
|---|---|---|
| Usual Care Phase | No intervention | –Participants receive the site-specific usual transplant referral and evaluation pathway. Minimum study measurement is collected without activation of TORCH-ITAP. |
| TORCH-ITAP Phase | Experimental | Other: TORCH Integrated Transplant Access Pathway (TORCH-ITAP)The regional network implements TORCH-ITAP, including standardized identification and referral, common-data assessment, candidacy adjudication, donor-organ and match workflow, and structured navigation and traceability. |
Who may qualify
- Ages
- 0 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Confirmed congenital heart disease.
- Age from birth with no protocol-defined upper age limit.
- Advanced cardiac, pulmonary vascular, or cardiopulmonary deterioration meeting contemporary international criteria for transplant referral/evaluation, or previously documented transplant candidacy by an authorized program.
- Clinical presentation within the TORCH scope: heart transplantation; heart-lung transplantation; or, in selected congenital heart disease, bilateral lung transplantation with cardiac repair after multidisciplinary adjudication.
- Availability of the minimum baseline dataset required for standardized multidisciplinary evaluation and risk stratification.
Key exclusion criteria (5 listed)
- Absence of congenital heart disease or a transplant indication outside the TORCH congenital-heart-disease scope.
- No protocol-defined indication for transplant referral/evaluation after standardized review.
- A contemporary absolute contraindication to all transplant strategies applicable to the participant that is confirmed by multidisciplinary adjudication and is not considered reversible or re-evaluable under the protocol.
- Inability to obtain required informed consent/assent or to collect the minimum essential baseline dataset.
- A legal, regulatory, or safety condition that prohibits participation in research at the enrolling site.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TORCH Integrated Transplant Access Pathway (TORCH-ITAP)TORCH-ITAP is a multicomponent regional health-services pathway that standardizes early identification and referral, a common recipient dataset, multidisciplinary candidacy adjudication, structured donor-organ assessment, immunologic and anatomic-physiologic matching, preservation and transport traceability, and navigation of clinical, regulatory, logistical, and financial barriers. It supports authorized transplant pathways but does not allocate organs or supersede applicable law, competent authorities, or institutional authorization. | Other | TORCH-ITAP Phase |
Primary outcome
Percentage of Participants Completing Standardized Multidisciplinary Transplant Evaluation With a Documented Candidacy Decision
Time frame: Within 90 days after formal trial enrollment
Percentage of enrolled recipient participants who complete the protocol-defined minimum multidisciplinary transplant evaluation and receive a final documented candidacy decision within 90 days. Final decisions include candidate/active pathway, candidate with a documented reversible condition/temporarily inactive status, not a candidate under current conditions, or an alternative transplant strategy within protocol scope. Deferred/incomplete evaluation does not count as success. Participants who die before final decision remain in the denominator and are classified as failures.
5 secondary outcomes
Activation of an Official Transplant Pathway or Waitlist
Time frame: Within 6 months after candidacy decision
Receipt of Heart, Heart-Lung, or Selected Bilateral Lung Transplantation With Cardiac Repair
Time frame: Within 12 months after enrollment
Pretransplant Death or Irreversible Clinical Deterioration
Time frame: Within 12 months after enrollment
Utilization of TORCH-Evaluated Donor Organs
Time frame: At final disposition of each donor organ (implantation or documented non-use)
Patient and Graft Survival
Time frame: 30 days, 90 days, and 1 year after transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- TORCH-LATAM Institutional Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eliecer Villamizar De La Hoz., MD principal investigator
CardioVision International Tech, S.A.S. de C.V.
Questions about this trial
What is this clinical trial studying?
A study testing TORCH Integrated Transplant Access Pathway (TORCH-ITAP) in people with Congenital Heart Disease, run by CardioVision International Tech, S.A.S. de C.V..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eliecer Villamizar De La Hoz, MD (+50370876226, info@torch-latam.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Completing Standardized Multidisciplinary Transplant Evaluation With a Documented Candidacy Decision (time frame: Within 90 days after formal trial enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.